BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER HPL402

    MDR report key: 6995656 · Received November 2, 2017

    Report

    Report Number
    3010605276-2017-00004
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    August 3, 2017
    Report Date
    November 1, 2017
    Manufacturer
    APEX HEALTH CARE MFG., INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED THE MEDWATCH FORM 3500A FROM OUR CUSTOMER, (B)(4), AND THE CONTEXT STATED AS BELOW: IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, HEMODIALYSIS PATIENT ATTENDED REGULAR SCHEDULED DIALYSIS. AFTER COMPLETION OF DIALYSIS TREATMENT, PATIENT WAS LIFTED UTILIZING THE JOERNS HOYER LIFT MODEL WITH THE PATIENT'S OWN UNKNOWN MANUFACTURER SLING PAD. UPON LIFTING AND TRANSFERRING THE PATIENT FROM THE DIALYSIS RECLINER CHAIR TO THE PATIENT'S OWN MOTORIZED SCOOTER, THE PATIENT SLIPPED THROUGH THE SLING PAD AND LANDED ON THE FLOOR. THE 911 WAS CALLED AND PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT SUFFERED A RIGHT FEMORAL FRACTURE. UPON SPEAKING WITH THE FACILITY, THEY STATED "THE PATIENT AND FACILITY KNEW THE SLING WAS THE WRONG SIZE. PATIENT REFUSED TO USE A PROPER SIZED SLING." THE SLING MODEL AND MANUFACTURER ARE UNKNOWN AS THE SLING IS PATIENT OWNED. IT WAS ENTERED INTO (B)(4) SYSTEM TO HAVE THE LIFT RETRUNED TO (B)(4) FOR INVESTIGATION. AS OF THIS WRITING, WE HAVE NOT YET RECEIVE THE UPDATE MESSAGE FROM OUR CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776119 HOYER HPL402 PATIENT LIFT, PRODUCT CODE:FSA FSA APEX HEALTH CARE MFG., INC. HPL402

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization